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    <basicUdiDi>B-06977194141793</basicUdiDi>
    <tradeName>06977194141793</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:38.597Z</lastUpdated>
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    <udiDi>06977194141786</udiDi>
    <basicUdiDi>B-06977194141786</basicUdiDi>
    <tradeName>06977194141786</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:36.147Z</lastUpdated>
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    <udiDi>06977194141779</udiDi>
    <basicUdiDi>B-06977194141779</basicUdiDi>
    <tradeName>06977194141779</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:35.230Z</lastUpdated>
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    <udiDi>06977194141762</udiDi>
    <basicUdiDi>B-06977194141762</basicUdiDi>
    <tradeName>06977194141762</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:34.035Z</lastUpdated>
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    <udiDi>06977194141755</udiDi>
    <basicUdiDi>B-06977194141755</basicUdiDi>
    <tradeName>06977194141755</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:31.239Z</lastUpdated>
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    <udiDi>06977194141625</udiDi>
    <basicUdiDi>B-06977194141625</basicUdiDi>
    <tradeName>06977194141625</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0200901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:10.424Z</lastUpdated>
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    <udiDi>06977194141618</udiDi>
    <basicUdiDi>B-06977194141618</basicUdiDi>
    <tradeName>06977194141618</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0200801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:09.612Z</lastUpdated>
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    <udiDi>06977194141601</udiDi>
    <basicUdiDi>B-06977194141601</basicUdiDi>
    <tradeName>06977194141601</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0200701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:08.009Z</lastUpdated>
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    <udiDi>06977194141489</udiDi>
    <basicUdiDi>B-06977194141489</basicUdiDi>
    <tradeName>06977194141489</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0502003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:34.318Z</lastUpdated>
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    <udiDi>06977194141472</udiDi>
    <basicUdiDi>B-06977194141472</basicUdiDi>
    <tradeName>06977194141472</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0502002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:33.519Z</lastUpdated>
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    <udiDi>06977194141465</udiDi>
    <basicUdiDi>B-06977194141465</basicUdiDi>
    <tradeName>06977194141465</tradeName>
    <deviceName>AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0502001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:32.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752613</udiDi>
    <basicUdiDi>B-06976374752613</basicUdiDi>
    <tradeName>β-Human Chorionic Gonadotropin (β-HCG) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR029-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:46:28.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750909</udiDi>
    <basicUdiDi>B-06976374750909</basicUdiDi>
    <tradeName>Human chorionic gonadotropin (β-HCG) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Human chorionic gonadotropin (β-HCG) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR024-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:42:29.216Z</lastUpdated>
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  <row>
    <udiDi>06976202763255</udiDi>
    <basicUdiDi>B-06976202763255</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test Midstream</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHHCG-B103A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:28.944Z</lastUpdated>
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    <udiDi>06976202763248</udiDi>
    <basicUdiDi>B-06976202763248</basicUdiDi>
    <tradeName>hLH Ovulation Rapid Test Midstream</tradeName>
    <deviceName>hLH Ovulation Rapid Test Midstream</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHhLH-103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:28.138Z</lastUpdated>
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    <udiDi>06976202762784</udiDi>
    <basicUdiDi>B-06976202762784</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test</tradeName>
    <deviceName>hCG Pregnancy Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHHCG-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:12.500Z</lastUpdated>
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    <udiDi>06976202762654</udiDi>
    <basicUdiDi>B-06976202762654</basicUdiDi>
    <tradeName>HCG one step pregnancy Rapid Test</tradeName>
    <deviceName>HCG one step pregnancy Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHHCG-B102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:52.831Z</lastUpdated>
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    <udiDi>06976202762128</udiDi>
    <basicUdiDi>B-06976202762128</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test</tradeName>
    <deviceName>hCG Pregnancy Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHHCG-B502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:19.931Z</lastUpdated>
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    <udiDi>06976202762012</udiDi>
    <basicUdiDi>B-06976202762012</basicUdiDi>
    <tradeName>hLH Ovulation Rapid Test</tradeName>
    <deviceName>hLH Ovulation Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHhLH-102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:34:32.697Z</lastUpdated>
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  <row>
    <udiDi>06975388111539</udiDi>
    <basicUdiDi>B-06975388111539</basicUdiDi>
    <tradeName>06975388111539</tradeName>
    <deviceName>LH Test Kit (Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0033-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:37.923Z</lastUpdated>
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